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Brazilian study investigates why some HIV patients fail key drug combo

NCT ID NCT04453436

Knowledge-focused Sponsor: Federal University of São Paulo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tracks 2,500 people with HIV in Brazil who are taking a common first-line treatment (tenofovir/lamivudine and dolutegravir) to see why some develop drug resistance. Researchers will test blood samples from those whose viral load remains detectable to look for resistance mutations. The goal is to gather real-world data to improve HIV care in similar settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors understand why some people develop drug resistance to common HIV medications, potentially improving future treatment guidelines.
What could go wrong
This is an observational study, not a treatment trial. It only looks at people who have already failed therapy, so it cannot predict who will fail or test new treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

2,500 HIV positive Brazilian

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patints starting first line anti HIV treatment with Tenofovir/laimudine + Dolutegravir * No previous antiretroviral treatment * ≥ 18 ≤ 65 y.o Exclusion Criteria: • Not to be able to understand and sign the informed consent form

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Conditions

The condition(s) this trial relates to.

drug dependence HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DRUG HIV Resistance

Contacts and locations

Locations

  • Laboratório de Retrovirologia, EP2

    São Paulo, São Paulo, 04039-032, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.